drug facts

drug facts

SPL v4

SPL

SPL Set ID 6cc9e30c-dd32-42b2-890c-a8e026ed0cca

Route

oral

Published

Effective Date 2024-03-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

docusate (250 mg)

Inactive Ingredients

fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin polyethylene glycol, unspecified propylene glycol water sorbitol mannitol sorbitan

Identifiers & Packaging

Pill Appearance

Imprint: P20 Shape: capsule Color: orange Size: 20 mm Score: 1

Marketing Status

otc monograph drug active Since 2020-09-01

Purpose

Stool softener laxative

Description

Docusate sodium 250 mg

Medication Information

Uses

for relief of occasional constipation
this product generally produces a bowel movement within 12 to 72 hours

Purpose

Stool softener laxative

Directions

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
children under 12 years of age: ask a doctor

Other Information

each softgel contains: sodium 15 mg
store at 20º-25ºC (68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, propylene glycol, purified water, sorbitol special

Description

Docusate sodium 250 mg

Principal Display Panel

Extra Strength

Stool Softener

Docusate Sodium, 250 mg

Stool Softener Laxative

Stimulant free
Relief of occasional constipation

SOFTGELS

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Do Not Use

if you are presently taking mineral oil, unless directed by a doctor.

Package Label

EQUATE Extra Strength Stool Softener Laxative

Questions Or Comments?

Call 1-888-287-1915

Stop Use and Ask A Doctor If

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Softgel)

Docusate sodium 250 mg

Ask A Doctor Before Use If You Have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

Structured Label Content

Uses

for relief of occasional constipation
this product generally produces a bowel movement within 12 to 72 hours

Purpose

Stool softener laxative

Directions

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
children under 12 years of age: ask a doctor

Other Information (Other information)

each softgel contains: sodium 15 mg
store at 20º-25ºC (68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients (Inactive ingredients)

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, propylene glycol, purified water, sorbitol special

Principal Display Panel

Extra Strength

Stool Softener

Docusate Sodium, 250 mg

Stool Softener Laxative

Stimulant free
Relief of occasional constipation

SOFTGELS

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Do Not Use (Do not use)

if you are presently taking mineral oil, unless directed by a doctor.

Package Label

EQUATE Extra Strength Stool Softener Laxative

Questions Or Comments? (Questions or comments?)

Call 1-888-287-1915

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Docusate sodium 250 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

Advanced Ingredient Data

[{"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for relief of occasional constipation this product generally produces a bowel movement within 12 to 72 hours", "Purpose": "Stool softener laxative", "Directions": "adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor children under 12 years of age: ask a doctor", "Do not use": "if you are presently taking mineral oil, unless directed by a doctor.", "Package Label": "EQUATE Extra Strength Stool Softener Laxative", "Other information": "each softgel contains : sodium 15 mg store at 20º-25ºC (68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)", "Inactive ingredients": "edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, propylene glycol, purified water, sorbitol special", "Questions or comments?": "Call 1-888-287-1915", "Principal Display Panel": "Extra Strength Stool Softener Docusate Sodium, 250 mg Stool Softener Laxative Stimulant free Relief of occasional constipation SOFTGELS Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716 TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.", "Stop use and ask a doctor if": "you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Active ingredient (in each softgel)": "Docusate sodium 250 mg", "Ask a doctor before use if you have": "stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:53.919073 · Updated: 2026-03-14T23:02:40.652524